Favipiravir and/or Nitazoxanide: a Randomized, Double-blind, Placebo-controlled Trial of Early Antiviral Therapy in COVID-19 (FANTAZE)

Smith et al., NCT04918927, FANTAZE, NCT04918927

Mar 2023

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120 patient favipiravir early treatment RCT with results not reported over 1.5 years after completion.

The protocol has been published1.

Potential risks include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity2-6.

2 favipiravir RCTs have results missing long after expected7,8
The trials report total actual enrollment of 1,128 patients.

Important missing comments or errors? Let us know.

Study covers favipiravir and nitazoxanide.

1. trialsjournal.biomedcentral.com, trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06533-0.trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06533-0.

2. Zhirnov et al., Favipiravir: the hidden threat of mutagenic action, Journal of microbiology, epidemiology and immunobiology, doi:10.36233/0372-9311-114.elpub.ru, doi.org.

3. Waters et al., Human genetic risk of treatment with antiviral nucleoside analog drugs that induce lethal mutagenesis: the special case of molnupiravir, Environmental and Molecular Mutagenesis, doi:10.1002/em.22471.wiley.com, doi.org.

4. Hadj Hassine et al., Lethal Mutagenesis of RNA Viruses and Approved Drugs with Antiviral Mutagenic Activity, Viruses, doi:10.3390/v14040841.mdpi.com, doi.org.

5. Shum, C., An investigational study into the drug-associated mutational signature in SARS-CoV-2 viruses, The University of Hong Kong, PhD Thesis, hub.hku.hk/handle/10722/344396.hku.hk.

6. Shiraki et al., Convenient screening of the reproductive toxicity of favipiravir and antiviral drugs in Caenorhabditis elegans, Heliyon, doi:10.1016/j.heliyon.2024.e35331.sciencedirect.com, doi.org.

7. Smith et al., Favipiravir and/or Nitazoxanide: a Randomized, Double-blind, Placebo-controlled Trial of Early Antiviral Therapy in COVID-19 (FANTAZE), NCT04918927, clinicaltrials.gov/study/NCT04918927.clinicaltrials.gov.

8. Kara et al., Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19, NCT04411433, clinicaltrials.gov/study/NCT04411433.clinicaltrials.gov.

Smith et al., 21 Mar 2023, Double Blind Randomized Controlled Trial, Mexico, trial NCT04918927 (history) (FANTAZE). Contact: jorgeep@unam.mx.

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